Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing

Background

For quite some time now, questions such as "What happens if the Limulus populations are damaged, e.g. by environmental changes? or "Should we not, as far as possible, reduce the use of the animals" have been increasingly raised in the area of testing for endotoxins. In this context, the use of alternative test methods or recombinant reagents is gaining in importance. This is also reflected in the development of Pharmacopoeias in Europe, Japan and the USA. We reported about the  European Pharmacopoeia (Ph. Eur.) draft chapter - 2.6.32. Test for bacterial endotoxins with recombinant factor C (rFC) which was published in spring for commenting and the USP chapter <85> Bacterial Endotoxin test is under discussion to.

Current JP Draft

The Japanese Pharmacopoeia recently published a draft of a new chapter for comment. "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin Assay". The alternative test discussed in the document is based on the fact that factor C plays an important role in the endotoxin reaction with the classic LAL reagent - a coagulation reaction in the form of a reaction cascade with various serine proteases. This factor can also be produced recombinantly and serve as the basis for an alternative test system.

The present chapter deals accordingly with the existing systems, the possible alternatives and the requirements that are relevant for the conversion. After the Japanese version there is now an  English version of the draft  available. The draft is open for comment until 30 October.

Fore more details please read "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin Assay".

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